Sprayology Recalls SleepEase Homeopathic Oral Spray Due to CGMP Deviations
Sprayology is recalling 5,393 bottles of SleepEase Homeopathic Oral Spray nationwide due to manufacturing deviations that could result in possible microbial contamination.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a theoretical risk of microbial contamination without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sprayology is recalling 5,393 bottles of SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml). The product is identified by NDC 61096-0001-1 and Tester NDC 6196-1001-1. The recall covers all lots within the expiration date.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured by a contract manufacturer under conditions that could result in possible microbial contamination.
The affected product was distributed nationwide in the USA. Consumers should stop using the product and contact Sprayology for further instructions.
The recalled product
- Product
- SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1
- Manufacturer
- Sprayology
- Category
- Drug — Homeopathic
- Hazard
- Affected units
- 5,393
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Sprayology under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
Same manufacturer · Sprayology
See all →- ModerateSprayology Recalls Body Balance Homeopathic Oral Spray Due to CGMP Deviations
FDA (Drugs) · 2018-11-07
- ModerateSprayology Recalls PMS Support Homeopathic Oral Spray Due to CGMP Deviations
FDA (Drugs) · 2018-11-07
- ModerateSprayology Recalls Diet Power Homeopathic Oral Spray Due to CGMP Deviations
FDA (Drugs) · 2018-11-07
- SevereSprayology Recalls Snore Soother Homeopathic Oral Spray Due to CGMP Deviations
FDA (Drugs) · 2018-11-07
- HighSprayology Recalls Man Power Homeopathic Oral Spray Due to CGMP Deviations
FDA (Drugs) · 2018-11-07
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15